Lamisil PATIENT COUNSELING INFORMATION

Patients taking Lamisil Tablets should receive the following information and instructions:

• Patients should take one 250 mg tablet once daily for 6 weeks for treatment of fingernail onychomycosis or once daily for 12 weeks for treatment of toenail onychomycosis. The optimal clinical effect is seen some months after mycological cure and cessation of treatment due to the time period required for outgrowth of healthy nail.

• Patients should be advised to immediately report to their physician any symptoms of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain, jaundice, dark urine or pale stools. Lamisil Tablets treatment should be discontinued.

• Patients should be advised to report to their physician any signs of taste disturbance, smell disturbance and/or depressive symptoms. Lamisil Tablets treatment should be discontinued.

• Patients should be advised to immediately report to their physician or get emergency help if they experience any of the following symptoms: hives, mouth sores, blistering and peeling of skin, swelling of face, lips, tongue, or throat, difficulty swallowing or breathing. Lamisil Tablets treatment should be discontinued.

• Patients should be advised to report to their physician any symptoms of new onset or worsening lupus erythematosus. Symptoms can include erythema, scaling, loss of pigment, and unusual photosensitivity that can result in a rash. Lamisil treatment should be discontinued.

• Photosensitivity reactions have been reported with the use of Lamisil. Patients should be advised to minimize exposure to natural and artificial sunlight (tanning beds or UVA/B treatment) while using Lamisil.

• Measurement of serum transaminases (ALT and AST) is advised for all patients before taking Lamisil Tablets.

• Patients should be advised that if they forget to take Lamisil Tablets, to take their tablets as soon as they remember, unless it is less than four hours before the next dose is due. Patients should also be advised that if they take too many Lamisil Tablets they should call their physician.